FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
K Number: K072988
·
Decision Feb 21, 2008
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
34
Applicant Total
34
Review Days
121
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Basic Information
- Device Name
- NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
- K Number
- K072988
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nipro Medical Corporation
- Date Received
- October 23, 2007
- Decision Date
- February 21, 2008
- Product Code
- FIB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FIB | Protector, Transducer, Dialysis | FDA class 2 | Gastroenterology, Urology |
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